1. Field of the Invention
The present invention relates generally to medical devices and methods. More particularly, it relates to devices and methods for the delivery of substances to breast milk ducts.
2. Background
The current state of the ductal access art is that the ducts in a breast are accessed one-by-one with a catheter. The human breast has from 6-12 ducts. This process of duct-by-duct access has many disadvantages, including that the process is slow and that it is very difficult after finishing lavage of one duct to know which of the other ducts of a breast have or have not been lavaged. Thus, under the one-duct-at-a-time duct lavaging or accessing system it is easy to miss a duct or access a duct twice. The present invention at least partly overcomes these deficiencies.
U.S. Pat. No. 5,763,415 to Sukumar claims a method of treating the ductal epithelium of a mammary gland prophylactically for cancer by ductal cannulation and administration of a vector comprising thymidine kinase into the duct. The delivery of epithelium-destroying agents to breasts by ductal cannulation is described in WO 97/05898.
Various methods and techniques of duct-by-duct access have been described, including methods described in Love and Barsky, (1996) Lancet 348: 997-999, and presentations about ductal access made in Love, (1992) xe2x80x9cBreast duct endoscopy: a pilot study of potential technique for evaluating intraductal disease,xe2x80x9d presented at 15th Annual San Antonio Breast Cancer Symposium, San Antonio, Tex., Abstract 197; Barsky and Love (1996) xe2x80x9cPathological analysis of breast duct endoscoped mastectomies,xe2x80x9d Laboratory Investigation, Modern Pathology, Abstract 67; and Lewis (1997) Biophotonics International, pages 27-28, May/June 1997.
A company called Diagnostics, Inc. formed in 1968, produced devices to obtain breast ductal fluid for cytological evaluation. The devices included a breast duct catheter to infuse fluid into and collect fluid from individual ducts. The devices were sold prior to May 28, 1976 for the purpose of collecting breast ductal fluid for cytological evaluation.
A patent application entitled xe2x80x9cMethods and kits for obtaining fluid and cellular material from breast ducts,xe2x80x9d U.S. Ser. No. 09/067,661 filed Apr. 28, 1998, and its continuation-in-part, U.S. Ser. No. 09/301,058 filed Apr. 28, 1999, describe and claim infusing a small amount of fluid into the duct and collecting the fluid using a catheter. Related applications include U.S. Ser. No. 60/143,476 and 60/143,359, both filed Jul. 12, 1999, Ser. No. 60/134,613, filed May 18, 1999, and Ser. No. 60/114,048 filed Dec. 28, 1998, all of which are herein incorporated by reference in their entirety. Provisional application No. 60/170,997, filed Dec. 14, 1999, and non-provisional application No. 09/473,510, filed Dec. 28, 1999 describe methods and apparatus for delivering a substance to a breast duct.
Apparatus for accessing two or more ductal networks in a breast comprise two or more individual access probes, each probe having a lumen and being configured for insertion through an orifice of a ductal network. The apparatus further comprises a manifold having an inlet for receiving a fluid and two or more outlets, one each for distributing and/or collecting the fluid to each of the probe lumens. The manifold preferably connects to more than two probes, usually to at least three probes, more usually to at least six probes, and even more usually to at least twelve probes. Optionally, the probes may be selectively and removably connected to the manifold in any number up to the total number. In one embodiment, the total number of probes are pre-connected to the manifold and at least some of the probes have valves or other means for selectively closing the probe lumen. The apparatus can further comprise a pump that connects to the manifold to deliver and/or aspirate a fluid to the manifold. The pump can comprise a syringe that is pre-loaded with a wash or other fluid. Each probe lumen is optionally connectable to a collection lumen to collect a sample from each duct separately.
The apparatus can further comprise a plurality of fluid collection tubes, and the tubes are connected or connectable to the probe lumen. Thus is provided an apparatus for accessing a plurality of ductal networks in a breast, comprising a plurality of individual access probes, each probe having a lumen and being configured for insertion through an orifice of a ductal network; and a manifold having an inlet for receiving a fluid and a plurality of outlets for distributing the fluid to each of the probe lumens.
A method for delivering a substance to two or more ductal networks in a breast is provided comprising establishing access to two or more ductal network in the breast through a ductal orifice of each ductal network; and thereafter delivering a substance to and/or collecting a fluid from two or more of the ductal networks. Establishing access comprises inserting an access probe in each ductal orifice to be accessed. At least some of the access probes are fluidly connected by a manifold so that substance may be delivered simultaneously to the connected probes through the manifold. All of the access probes are fluidly connected to the manifold so that fluid may be delivered simultaneously to all probes. The substance is delivered simultaneously to all of the accessed ductal networks. Fluid can be collected in separate receptacles for each ductal network. The access can be established to each of the ductal networks in a breast.
A method for delivering a fluid to two or more ductal networks in a breast is provided comprising locating two or more ductal networks in a nipple of the breast; inserting an access probe through an orifice of each of the located ductal networks; and infusing the fluid through a manifold to each of the probes. The method further comprises connecting individual probes to the manifold so that the number of probes connected to the manifold is the same as the number of probes inserted into ductal orifices.
The method further comprises providing an assembly comprising a number of access probes, greater than the number of ductal orifices. The access probes can be pre-loaded on the manifold, while selectively blocking those access probes connected to the manifold which are not inserted to a ductal network. The method can further comprise collecting fluid from each accessed ductal network, wherein the fluid is collected separately so that no one fluid from a ductal network is mixed with fluid from another ductal network.
A kit for delivering a substance to a two or more of ductal networks in a breast, is provided comprising two or more of probes each having a lumen and being configured for introduction into a ductal network of the breast, and instructions for use setting forth a method according to any of claims identified herein. A kit is also provided comprising a manifold having an inlet and at least twelve outlets, and at least twelve access probes connectable to the outlets on the manifold. The access probes are configured for insertion through an orifice of a ductal network of a breast. The kit can further comprise a separate collection receptacle for each probe.